A Study to Assess Safety of ImbruvicaTM in Indian Participants With Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma Who Have Received at Least One Prior Therapy or Chronic Lymphocytic Leukemia With 17p Deletion

Sponsor
Johnson & Johnson Private Limited
Study ID
NCT03190330
Phase
PHASE4
Status
Completed

Conditions

  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Lymphoma, Mantle-Cell

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ibrutinib 420 mg — DRUG
    Ibrutinib capsule administered orally at a dose of 420 mg for CLL participants.
  • Ibrutinib 560 mg — DRUG
    Ibrutinib capsule administered orally at a dose of 560 mg for MCL participants.

Study Details

The primary purpose of this study is to evaluate the post-marketing safety of ImbruvicaTM (ibrutinib capsule 140 milligram \[mg\]) under actual conditions of use, and to understand the incidence of adverse events (AEs) (serious and non-serious AEs).

Key Dates

Start date
Jun 26, 2019
Status verified
May 2025
Primary completion
May 3, 2023
Completion
May 3, 2023

Study Design

Enrollment
75 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Ibrutinib
    Participants will receive ibrutinib 420 milligram (mg) (three 140 mg capsules) as a single daily dose for chronic lymphocytic leukemia (CLL) and 560 mg (four 140 mg capsules) as a single daily dose for mantle cell lymphoma (MCL) for up to 12 months or till disease progression, whichever is earlier.

Primary Outcome Measure

Number of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Day 1 up to 30 days after last dose of study drug (up to 13 months) ]

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